NEW ORLEANS—Testosterone replacement therapy (TRT) is not associated with an increased risk of myocardial infarction (MI) or other serious thrombotic events in men older than 65 years, according to study data presented at the American Urological Association annual meeting.

In a retrospective study, a team at Baylor College of Medicine in Houston led by first author Ranjith Ramasamy, MD, and senior author Larry Lipshultz, MD, evaluated the prevalence of thrombotic events—MI, cerebrovascular accidents (CVA), or pulmonary embolism (PE)—among 217 men aged 65 years and older who had hypogonadism (testosterone level below 300 ng/dL). Of these, 153 were on TRT and 64 were naïve to TRT (controls). The TRT and control groups had mean ages of 74 and 75 years, respectively.

After a mean follow-up of 3.8 years for the TRT group and 3.4 years for the control group, the researchers observed no statistically significant differences between the groups in the occurrence of MI, CVA, or PE. The control group, however, had a significantly higher prevalence of death from any cause, with 1 death occurring in the TRT group versus 6 deaths in the control arm.

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“Testosterone therapy appears to be safe in elderly men as long as they are closely followed with regular physical exams and blood tests,” Dr. Ramasamy told Renal & Urology News

Though the study was retrospective and limited by small sample size, it overcomes some of the limitations of large epidemiologic studies that have suggested an elevated risk of cardiovascular events associated with TRT use, he pointed out. For example, the study had a long follow-up and included an age- and comorbidity-matched control group of hypogonadal men naïve to TRT. All men had at least 2 testosterone measurements. In addition, thrombotic events were verified through patient calls, and mortality was verified using the National Death Index. The study is in press in Urology.